Vastern Consultants offer a broad range of services as shown below. Please click on a heading for further details or contact us to discuss your requirements further:

• Quality Management Systems
• Auditing
• Interim Quality Support
• Inspection Management
• Additional Services

Quality Management Systems

QMS Design and Implementation Projects

• Design and implementation of an effective, individually tailored QMS appropriate to the activities conducted &/ or outsourced by the client, and appropriate to the stage of Development;
• Gap analysis and integration with existing systems, or system design and development;
• Preparation of a Quality Manual and supporting policies.

Standard Operating Procedures (SOPs)

• Writing SOPs in compliance with Quality management principles and GMP requirements;
• Review of existing SOPs to assure compliance with current regulatory expectations.

Auditing

Internal Audits

• Conduct of impartial internal audits of existing Quality Management System and GMP activities;
• Mock inspections in preparation for potential due diligence.

External Audits of Outsourced Operations/ Due Diligence

• Routine and ‘for cause’ audits of Contract Manufacturing Organisations (CMOs) and GMP contract laboratories;
• Audits of third party storage and distribution agents, including cold chain custody and ultra low temperature storage;
• Evaluation of potential new outsourced partners/ vendor qualification.

Documentation Audits

• Review of Batch Manufacturing Records (BMRs);
• Review of Quality and CMC sections of regulatory submissions;
• Review of Clinical Trial Protocols and Amendments against the requirements of ICH GCP.

Interim Quality Support

• Troubleshooting;
• Interim senior QA support;
• Providing independent oversight of Quality operations;
• Ad hoc advice on a wide range of Quality and CMC topics.

Inspection Management

• Conduct of mock inspections;
• Provision of customised inspection-readiness staff training;
• Assistance in identifying appropriate Corrective and Preventative Actions (CAPAs).

Additional Services

• Preparation and/ or review of existing Technical/ Quality Agreements;
• Preparation and/ or review of Product Specification Files (PSFs);
• Training: On-site Good Manufacturing Practice (GMP) and Quality training courses tailored to meet the client’s needs;
• QP Batch Certification- for both Marketed products and Investigational Medicinal Products (IMPs).